Individual Molecular MRD Monitoring for MDS Patients After Allo-SCT
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|ClinicalTrials.gov Identifier: NCT02872662|
Recruitment Status : Recruiting
First Posted : August 19, 2016
Last Update Posted : January 30, 2018
|Condition or disease|
|MDS SCT MRD|
This study aims to develop highly sensitive methods for early detection of relapse based on the patients unique mutations.
Screening of mutations In collaboration with Department for clinical genetics, Uppsala, an initial screening of mutations will be performed using the commercial TrueSight© sequencing panel which includes 54 genes recurrently mutated in myeloid diseases. Based on the mutations identified, PCR-primers for all patient-specific mutations will be designed. Patients without any mutation will be excluded from the study. The mutational screen is performed as soon as a patient is being identified as a potential candidate for allogeneic stem cell transplantation (SCT) and evaluated for most optimal pre-SCT treatment. The patient is included in the study before the bone marrow sampling preceding SCT. In case a mutational screen has not been performed before pre-SCT MDS treatment, a mutational screen from the diagnostic national biobank sample (peripheral blood) can be performed.
MRD surveillance After the transplantation, peripheral blood samples will be collected once monthly; and bone marrow samples will be collected at month 1, 3, 6 after SCT followed by sampling every third month until relapse or death. The samples are sent to Biobanking and Molecular Resource Infrastructure of Sweden (bbmri) who will extract DNA and store the samples. By using the highly sensitive digital-PCR method the investigators will determine the size of the different clones at the different time points. In addition to biobanking of DNA, bbmri will collect and vital froze mononuclear cells (MNCs) to be used for experimental studies.
Statistics Landmark analyses will be performed at different time points after SCT, using presence of MRDs as a risk factor included in a multivariate analysis. Furthermore, the investigators will calculate sensitivity, specificity and predictive value for MRDs in relation to relapse. For each specific mutation, with high enough frequency in the cohort, the investigators will define cut-off values of the MRD where relapse is impending.
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Individual Molecular Minimal Residual Disease (MRD) Monitoring for Patients With MDS and Mixed MDS/MPN Treated With Allogeneic Stem Cell Transplantation|
|Actual Study Start Date :||August 2016|
|Estimated Primary Completion Date :||August 2019|
|Estimated Study Completion Date :||August 2019|
- Level of variant allele frequency (MRD) associated with full hematological relapse [ Time Frame: From inclusion up to end of study (August 2019) ]MRD is a quantative variable defined as variant allele frequency of patient-specific mutations. The association between MRD and relapse and survival will be studied.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02872662
|Contact: Magnus Tobiasson, PhDemail@example.com|
|Department of Hematology, Aarhus University Hospital||Recruiting|
|Aarhus, Denmark, 8000|
|Department of Hematology, Rigshospitalet Univsersity Hospital||Recruiting|
|Contact: Lars Kjeldsen|
|Department of Medcine, Haukeland University Hospital||Recruiting|
|Contact: Astrid Olsnes Kittang|
|Department of Hematology, Rikshospitalet University Hospital||Recruiting|
|Oslo, Norway, 0027|
|Department of Hematology and Coagulation, Sahlgrenska University hospital||Recruiting|
|Gothenburg, Sweden, 413 45|
|Department of Hematology, Lund University Hospital||Recruiting|
|Lund, Sweden, 221 85|
|Department of Hematology, Karolinska University Hospital||Recruiting|
|Contact: Eva Hellstrom-Lindberg|
|Department of Hematology, Akademiska University Hospital||Recruiting|
|Uppsala, Sweden, 751 85|
|Principal Investigator:||Eva Hellström-Lindberg, Prof||Karolinska Institutet|